Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-04 @ 6:05 PM
Study NCT ID:
NCT06271668
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-10
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Decision Support to Improve System Naloxone Co-prescribing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D040261', 'term': 'Harm Reduction'}, {'id': 'D000083682', 'term': 'Opiate Overdose'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D062787', 'term': 'Drug Overdose'}, {'id': 'D063487', 'term': 'Prescription Drug Misuse'}, {'id': 'D000076064', 'term': 'Drug Misuse'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone', 'timeFrame': '18 months', 'description': 'The number of high-risk opioid encounters where a naloxone prescription was written with the opioid divided by the total number of encounters where a high-risk opioid prescription was written.'}], 'secondaryOutcomes': [{'measure': 'Clinical decision support (CDS) acceptance rate', 'timeFrame': '18 months', 'description': 'The number of times providers accepted the Clinical decision support (CDS) suggestion and co-prescribed naloxone with a high-risk opioid divided by the total number of times a high-risk opioid prescription triggered the CDS alert.'}, {'measure': 'Subsequent opioid overdose/poisonings rates', 'timeFrame': 'Six months after an encounter where the naloxone clinical decision support fired for the provider', 'description': 'The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following the index visit with a high-risk opioid prescribed.'}, {'measure': 'Naloxone dispensed rate', 'timeFrame': 'In the 3 days after the naloxone prescription is written', 'description': 'The number of patients who were dispensed a naloxone prescription divided by the number of naloxone prescriptions written.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medication Abuse', 'Harm Reduction', 'Opioid Overdose', 'Opioid Prescribing']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months.', 'detailedDescription': 'Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving an opioid prescription at discharge from inpatient/ED or close visit in outpatient settings where the clinical decision support (CDS) is implemented\n\nExclusion Criteria:\n\n* Patients \\<12 and \\>89 year of age\n* Cancer diagnosis\n* Hospice care/palliative care\n* Sickle cell disease diagnosis\n* Patients who arrived in error\n* Patients who were triaged to obstetrics'}, 'identificationModule': {'nctId': 'NCT06271668', 'briefTitle': 'Clinical Decision Support to Improve System Naloxone Co-prescribing', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Clinical Decision Support to Improve System Naloxone Co-prescribing', 'orgStudyIdInfo': {'id': '23-2356'}, 'secondaryIdInfos': [{'id': 'R61DA057610', 'link': 'https://reporter.nih.gov/quickSearch/R61DA057610', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clinical Decision Support (CDS): Naloxone Alert', 'description': 'Encounters where the naloxone clinical decision support (CDS) alert fired. CDS logic is programmed to fire alert when a provider places and order for a high-risk opioid analgesic prescription to a patient without an active naloxone prescription.\n\nHigh-risk prescription logic to trigger the Naloxone CDS:\n\n\\[(NOT 1 AND (2 AND AT LEAST 1 OF (3, 4, 5, 6))) AND 7 AND NOT 8\\]\n\n1. ACTIVE OR PENDED NALOXONE PRESCRIPTION ORDER\n2. OPIOID SCRIPT BEING PLACED CRITERIA\n3. DAILY Milligram Morphine Equivalent (MME) \\>=90 UNSIGNED ORDER\n4. DAILY MME \\>=90 EXISTING\n5. DIAGNOSIS OF OPIOID USE DISORDER\n6. DIAGNOSIS HISTORY OF OPIOID OVERDOSE\n7. PROVIDER LOGGED INTO ELLIGIBLE DEPARTMENTS\n8. DISCHARGE TO HOSPICE', 'interventionNames': ['Other: Naloxone Co-prescribing Clinical Decision Support (CDS)']}, {'label': 'Usual Care', 'description': 'Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care.'}], 'interventions': [{'name': 'Naloxone Co-prescribing Clinical Decision Support (CDS)', 'type': 'OTHER', 'description': 'Clinical decision support in the form of an EHR-integrated, provider facing alert suggesting (a) the opioid medication order is considered high risk for overdose and (b) to nudge providers to add a naloxone prescription to the opioid prescription to mitigate risk in the event of an overdose.', 'armGroupLabels': ['Clinical Decision Support (CDS): Naloxone Alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jason A Hoppe, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'url': 'https://www.icpsr.umich.edu/web/pages/NAHDAP/index.html', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be provided to NAHDAP after study results are published in peer-reviewed journals.', 'ipdSharing': 'YES', 'description': 'De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.', 'accessCriteria': 'Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}